Evaporation residue cross sections for the reaction 16 O + 194 Pt were measured at beam energies in the range 75.4-103.1 MeV using the gas-filled separator Hybrid Recoil Mass Analyzer at the Inter University Accelerator Centre, New Delhi. The transmission efficiency of the separator was obtained using the calibration system 16 O + 184 W and a Monte Carlo simulation code. Measured evaporation residue cross sections were fitted with statistical model calculations using Kramers' formula. The present measurement provides further evidence for the onset of dissipative forces in fission in the mass ∼200 region.
A new ultra-performance liquid chromatographic (UPLC) method has been developed and validated for quantification of substances related to varenicline tartrate, process-related and degradation products, in pharmaceutical formulations. Chromatographic separation of six impurities was performed on a reversed phase column. The method was validated for linearity, limits of detection and quantification, accuracy, precision, and selectivity. The calibration plots obtained for the six impurities were linear over the range 0.005-0.30%. The relative standard deviations (s r ) of intra and inter-day experiments were less than 1.0%. The detection limits ranged between 0.002 and 0.004%, depending on the impurity. The proposed UPLC method was successfully applied to quantification of varenicline impurities in its pharmaceutical formulation.
Analytical techniques must be sensitive, specific, and accurate to assess the active pharmaceutical ingredients in pharmaceutical dosage forms. The quality‐by‐design (QbD) application has proven to be a practical method for magnifying HPLC operations. This article discusses the successfully developed QbD‐based stability‐indicative LC method for evaluating acetaminophen, caffeine, and aspirin (ASP) in tablet dosage form. To achieve the necessary chromatographic separation, Milli‐Q water, methanol, and glacial acetic acid were employed in the following ratios: 63:35:2 (v/v/v) for mobile phase A and 18:80:2 (v/v/v) for mobile phase B. The flow rate, column temperature, and detecting wavelength were 1.0 ml/min, 40°C, and 275 nm, respectively, and an InertSustain C18 analytical column (150 × 4.6 mm, 3 μm) was used. Linearity was between 10.0 and 150.0 μg/ml for ASP and acetaminophen and between 2.6 and 39.0 μg/ml for caffeine. The accuracy findings were more than 97%, and the correlation coefficient for all three components was found to be greater than 0.999. The validated HPLC method yielded reliable and accurate results. ASP was shown to be vulnerable to both acid and alkaline hydrolysis in the forced degradation study. The described method is capable of separating the degradants produced during stress testing and is regarded as stability indicating. The proposed method can be used for a wider range of other formulations with an appropriate diluent selection and sample preparation procedure optimization.
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